2012-01-15 TSC WGM SDO Activities Minutes

TSC Sunday Q4 Agenda - 2012 Jan WGM San Antonio, TX USA

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TSC HL7 activities with other SDOs Meeting Location: TBD		Date: 2012-01-15 Time: Sunday Q4
Facilitator	Austin Kreisler	Note taker(s)	Lynn Laakso
Opportunity for HL7 WGM attendees to review activities in collaboration with other SDOs such as IHE, OMG, and the JWG and JIC, and provide comment.
Attendees:

Agenda

Welcome and Introduction - Austin Kreisler

SDO liaison activities and review of each JIC-sponsored event having HL7 engagement (25 mins)

Attached reports:

• HL7 activities with AHIP: Maria Ward
• HL7 activities with ADA: Pat Van Dyke
• HL7 activities with CDISC: Bron Kisler for Becky Kush reports on CDISC-HL7 projects for Cardiology and Tuberculosis
  • CV Domain Analysis Model R2.0 was balloted Sept 2011 as part of the National Cardiovascular Research Infrastructure (NCRI) project under an NHLBI grant. The contents of this release expanded on the initial Cardiology DAM R1 to include content for diagnosis, treatment and management of patients experiencing coronary artery disease and heart failure. Release 2.0 contains roughly 350 data elements. Release 2.0 passed ballot, but the team postponed publishing to make changes and update based on public review comments. Those updates were balloted in Release 2.1 in December; comments are being reconciled in the Clinical Interoperability Council this week.
    • In parallel to this work, the NCRI team together with CDISC has mapped most of the data elements from CV DAM R2.0 in the CDISC standard for regulatory submission - SDTM. As a result of the mapping, six new SDTM domain are in the works. The NCRI team is collaborating with CDISC and NCI to prepare the data elements and value sets for inclusion in CDISC controlled terminology and publication in the NCI EVS terminology environment. Roughly 350 value set terms and half the data elements from the DAM will be submitted for comment in Feb. Those remianing will be released for review and comment later this year.
    • HL7 CIC approved Release 3 of the CV DAM in September. R3 will expand the content of the DAM to include data elements related to Cardiac Imaging, required to collect and evaluate clinical imaging data across clinical trials. This work reflect a multi-stakeholder initiative, partially funded under FDA CDER's data standards grant program. It is being led jointly by FDA, ACC and Duke. Once again, the data elements identified will be represented in CDISC SDTM and published in NCI EVS. The CV imaging work is happening in concert with broader imaging standards development underway by CDISC and NCI. Future work for the CV activities will include the data elements needed to support data collection and evaluation of the standardized cardiovascular endpoint definitions released by FDA.
  • TB Domain Analysis Model R1.0 was finalized in early 2009 which included 139 TB data elements for diagnosis and treatment of pulmonary TB. Similar to DV, this represented a collaborative project between Duke, CDISC and HL7 under an NIH grant. Due to this work, the standard data collection elements and CDISC SDTM standard have seen significant implementations by US CDC and global pharmaceutical companies and now fall under an FDA legacy data conversion project using several CDC datasets. CDISC and HL7 CIC representatives are refining (and will eventually extend) the TB data standard under a new initiative launched by the Gates Foundation, Global TB Alliance and the Critical Path Institute known as Critical Path to new TB Drug Regimens or CPTR. Future work will seek to expand focus to include Pediatric TB and HIV-TB co-infection.
  • CDISC is working on additional therapeutic area standards stated as US FDA and NIH priorities - Parkison's, Alzhemier's and Hepatitis-C, and will continue working with Duke and HL7 CIC on other emerging projects such as Schizophrenia. Additionally, CDISC will seek new projects in 2012 to address European Commission priorities such as Vaccine Safety and Autism.
• HL7 activities with CLSI:
• HL7 activities with CEN TC 251: Mark Shafarman
• HL7 activities with DICOM: Helmut Koenig
  • Radiology/Surgery/Pathology Orders Workflow (In cooperation with HL7 Anatomic Pathology WG + HL7 Orders and Observations WG)

    Develop an implementation guide for anatomic pathology orders that better captures data from the surgical or interventional radiology procedure that produced the specimen. In this project we will work on an HL7 v2.x Implementation Guide for pathology orders, including appropriate references to diagnostic and to peri-operative imaging - both biopsy guidance imaging (X-ray, ultrasound, MR) and photographic imaging (e.g., of specimen as excised). Particular consideration will be given to the operational issues in multi-department coordination.

  • Discussion on communication of contrast agent information and associated adverse events

    HL7 II WG / DICOM WG20 started a discussion on how to access and communicate relevant clinical information before and after contrast administration. Contrast agents used to improve medical imaging are not completely devoid of risk. In order to minimize the risks that are associated with the use of contrast media, the group will explore how they can be mitigated by exchanging relevant information between imaging and clinical information systems. Adverse events (contrast reaction, device failure) should be documented in imaging reports. We will evaluate the need for new structured document templates.

  • Cooperation with HL7 Structured Documents WG

    HL7 II WG / DICOM WG20 will continue the discussion on the development of CDA Imaging Report Templates and other harmonization topics.

• HL7 activities with DSMO: Maria Ward or Mary Lynn Bushman
• HL7 activities with GS1: Chuck Jaffe
• HL7 activities with IEEE (11073): Todd Cooper
• HL7 activities with IHE: Chuck Jaffe, Keith Boone
  • Integrating the Healthcare Enterprise (IHE) is an initiative by healthcare professionals and industry to improve the way computer systems in healthcare share information. IHE and HL7 have a Statement of Understanding most recently updated in May of 2011, and expiring in May of 2013.
  • IHE is organized into the 13 Domains. Each domain develops profiles (implementation guides), many of which incorporate the use of HL7 standards. A full list of IHE profiles can be found at http://www.ihe.net/Technical_Framework/index.cfm.
  • What follows is a list of recent and/or new activities in several IHE domains which presently use or anticipate the use of HL7 Standards. If HL7 members or committees would like more information about these activities, please contact keith.boone@ge.com, or the respective IHE Domain co-chairs for more detail.
    • Anatomic Pathology
    • Structured Orders (HL7 V2.5) - Updating Orders to support transmission of relevant clinical information in support of diagnosis for lung, breast, prostate and lung cancer
    • Cardiology - [CIRC] Cardiac Imaging Report Content (CDA)
    • Eyecare
      • [B-EYECARE] Basic Eyecare workflow (HL7 V2.5)
      • [ECAS] Eyecare Appointment scheduling (HL7 V2.5)
      • Eye exam reporting (CDA)
    • IT Infrastructure
      • [CR] Critical Results (HL7 V2.5)
      • [PEQ] Patient Encounter Tracking (HL7 V2.5)
    • PCC
      • [RCK] Retrieve clinical knowledge (InfoButton)
      • Review of CDA Consolidation impacts on PCC Technical Framework (CDA Consolidation)
    • PCD
      • [ADQ] Asynchronous Data Query is a transaction profile which will support a solicited mode of obtaining data from devices (HL7 V2.5)
      • [PCIM] Point of Care Identity Management will deal with the association of a patient identity to devices. (HL7 V2.5)***:
    • Pharmacy
      • [HMW] Hospital Medication Workflow (HL7 V2.5)
      • [PRE] Prescription (CDA)
      • [PADV] Pharmacy Advice (CDA)
      • [DIS] Dispense (CDA)
    • Quality, Research and Public Health
      • [QMD] Quality Measure Document (eMeasure)
      • [NANI] Newborn Admission Notification (HL7 V2.5, V3 Patient Administration)
• HL7 activities with IHTSDO: Russ Hamm reports: Several coordination activities have been ongoing between HL7 and IHTSDO.
  • IHTSDO is undertaking a review of the technical architecture of the IHTSDO Workbench, and HL7 has been asked to participate in an interview towards this effort. An interview was scheduled for the week of January 8th, 2012, and HL7 will be providing feedback on architectural and usability aspects of the Workbench, including:
    • Configuration and update complexity
    • Thick client vs. thin client implementation
    • Distributed terminology authoring capabilities
    • Terminology workflow automation
    • Terminology build process, and
    • General usability
  • The “Member’s Release” of the IHTSDO Workbench has been released and is available on the IHTSDO hosted Collabnet site. The Member’s release is based off the Migration Release, which is the version that IHTSDO has been using for developing the latest version of SNOMED-CT. This version should be considered by HL7 as the “starting point” for Workbench development activity. The Member’s release of the workbench is Standalone mode only however, and access is subject to the IHTSDO policy that enables the free use of English-language SNOMED CT terms and identifiers in international research databases, in complementary health IT standards, and in other projects and resources available worldwide. HL7 was approved to use SNOMED CT terms and identifiers in HL7 standards. Use of SNOMED CT Concept IDs and Descriptions in HL7 messages and documents that can be used by people in any country of the world. Groups and individuals authoring clinical value sets would require full access to SNOMED CT in order to perform that task safely, and so would need to obtain and adhere to an Affiliate license.

    NOTE: It should not be possible to extract and download SNOMED CT from these systems.

• HL7 Activities with NCPDP: Margaret Weiker
  • NCPDP WG2 – Product Identification has a task group, The Structure Product Labeling Activities Task Group tracks the activities of the SPL, offers suggestions to improve access and usability of the FDA Structured Product Label and Electronic Drug Listings, and monitors the work of the Guiding Coalition for feedback to the WG. This task group met during the WG meeting. The Coalition has sent seven letters to the FDA and is working on letters regarding Marketing Categories, Inner/Outer NDCs and Identifiers, and Freeness. Two letters, SPL Validation Dates and Fee Definition Update, were reviewed and approved at this meeting. They continue to collaborate with the HL7 SPL Leadership Team/SPL Working Group regarding issues with “Last Marketing Date/Marketing End Date”, “June/December Updates of the SPL” and the “SPL Validation Process”. They are also investigating the process whereby the Billing Unit Standard can be added to the SPL Indexing Files.
  • NCPDP WG11 – ePrescribing and Related Transaction has a task group, NCPDP/HL7 Pharmacist Functional Profile Task Group will discuss analyzing the functional profiles for NIST testing for meaningful use in the future.
  • NCPDP WG14 - Long Term and Post Acute Care (LTPAC) has 1 task groups that interfaces with HL7
    • Automation in LTPAC Task Group – This task group reported they are in the process of creating a white paper on the use of the HL7 messages in pharmacy.
• HL7 activities with NQF: Chuck Jaffe
• HL7 activities with NUCC: Maria Ward or Nancy Wilson-Ramon
• HL7 activities with OMG: Ken Rubin
• HL7 activities with Regenstrief/LOINC: Ted Klein
• HL7 activities with SCO: John Quinn or Chuck Jaffe
• Hl7 Activities with The Health Story Project: Joy Kuhl submits the attached report
• HL7 Activities with TIGER: Pat Van Dyke
  • HL7 continues to provide a ‘Breakfast for Nurses’ at each Working Group Meeting even though the original commitment ended in 2009. The meeting is regularly held on Tuesday mornings from 0700-0800. Nurses from the international community attend the breakfast and discuss their involvement in projects affecting the nurse communities in HL7 and other organizations such as HIMSS and IHE. It is a wonderful networking opportunity. We will seek presentations HL7 projects of interest to the clinical provider community such as Care Plans.
• HL7 activities with W3C: John Quinn
• HL7 Activities with WEDI: Maria Ward
• HL7 Activities with X12: Maria Ward

• BRIDG: Bron Kisler reports: BRIDG is a domain analysis model (and the DAM for RCRIM) resulting from a collaborative effort to produce a shared view of the dynamic and static semantics for biomedical research. Over the past several years, the collaborators (CDISC, NCI, HL7, FDA) have built BRIDG from the domain semantics of software and standards projects in clinical research. To date many NCI,FDA-HL7 RCRIM and CDISC standards have been harmonized and represented in BRIDG. BRIDG passed CDISC and HL7 ballots, and is currently going through the ISO process and being prepared for the 2nd phase of balloting - Draft International Standard or DIS. Currently, the BRIDG team is working on adding semantics regarding:
  • bone marrow transplants
  • cancer case report forms
  • statistical analysis
  • rare disease registry
  • human studies database
  • clinical trials registration and results
  • study design
  • clinical trial repository.

Panel discussion: (1 hour)

Streamlining current cross SDO processes - SDO perspective

• Panelists:
  • Jane Millar - IHTSDO
  • Bron Kisler
  • John Quinn - JIC
  • Christian Hay - GS1
  • Lisa Spellman - ISO TC/215 US TAG

Minutes

Convened at 3:48 PM

Welcome and Introduction - Austin Kreisler

• Keith Boone describes his report.
• Ted Klein notes as LOINC liaison the new version of LOINC 2.38 RELMA 5.5 available for download December 30th 2011. Looking to represent and maintain V3 value sets based on LOINC content in the HL7 repository and in the ballots.
  • He notes further that Vocab work group finding Canada having issues with ISO language codes with ISO 639 having 21090 only supports one code system but three exist. ISO 3166 country codes may offer solutions. IETF and other organizations citing specs which have been superseded. Editorial corrections may be needed to these superseded entries.
• Tim Buxton speaks on IDMP as JIC project. ISO about to go into FDIS ballot beginning next month. In HL7 the current activity is on messaging which balloted in January and will tie in substances more completely in next ballot.
• Harry Solomon for DICOM notes that one work item of interest in radiographic contrast agents and clinical decision support and medication administration reporting aspects.
• Bron Kisler with CDISC describes his report.

Panel discussion

Streamlining current cross SDO processes with focus on JIC.

• Bron notes this is the first time that JIC participated in a Sunday Q4 session. Why the individual SDOs of JIC are committed to working together. He describes the history and process. From initial three members processes established for other SDOs to join. Any member can advance a project that brings awareness to projects that individual SDO to SDO agreements would not bring. One thing we've done well is synchronizing ballot cycles and more is left to be done.
• Jane speaks to JIC bringing together SDOs in a single place. JIC is supposed to be independent of any individual SDOs, though meetings tend to be synchronized to ISO. She advocates JIC giving development advice early on in the cycle rather than after the first or subsequent ballots are underway. Would like to see a map defined with an SDO to show developers what happens once a ballot gets approved. Would like to avoid any one organization creating delay. Would also like to see early resolution of cross SDO issues for developers.
• John describes ballot coordination with a five-month ISO ballot and shorter HL7 ballot cycle. Seven ballots (including DCM) to coordinate with multiple SDO cycles poses a challenge. US-centric SDOs are represented in the SCO or Standards Charter Organization. John describes its membership of both SDO and non-SDO organizations.
• Christian Hay with GS1 describes its role in supply chain for over 20 industries, health care being one of them. The project they bring is Patient identification. He also describes issues in the expression of their standards as compared to SDOs in the way their standards are written, especially ISO.
• Lisa notes that TC215 seeks opportunities to collaborate with other SDOs to help get things done. Ballot alignment cycles were especially problematic with work that was already in progress; as the ballot coordination processes have been established the coordination should prove easier.
• Bron summarizes with SDOs working together they share individual strategic visions to look at business strategies an evaluate targets down the road. Beyond project-centric focus, they are now looking at standards needs for low-to-medium income developing countries. They kicked off that focus at a recent meeting.
• Christian added that the advocates the SKMT as an extraordinary tool to coordinate vocabularies.

Q&A

• Austin notes that the TSC approved 36 projects since the last HL7 meeting but none of them were JIC projects. Do the HL7 members see JIC as too painful to use? What can be done to reduce opposition and reduce pain points going through JIC.
  • John notes that the current JIC projects are ICSR, BRIDG, CTR&R, IDMP, EHR S FM R2.5, Patient ID. HL7 is not directly involved with the Patient ID project in JIC.
  • Bron notes that if the TSC thinks that a project would be good for JIC we need to ask John to bring it to them.
  • Richard D-H notes that other standards are already joint, like EHR-S FM R1, and the RIM. Modeling within the V3 environment and the RIM is applicable as universal standard but some modeling flowing from the RIM is not suitable for the international arena. He adds that the ballot cycle alignment is deceptive as ISO's 5 month ballot cycle is for normative content, where HL7's 30 day cycle is often used for multiple draft cycles.
  • John responds that ISO uses balloting for their final, workable standards where HL7 uses their balloting process differently.
  • Lisa adds her agreement that the cycle alignment is indeed more difficult than it seems.
• Ed notes that the challenge is to think of JIC differently, with a different ballot process with different expectations for material coming into the process and coming out of the process.
  • Bron notes that it's a good point. The user experience is different in each SDO and they're looking to test a way to integrate that user experience.
• Max asks on ISO 13940 as JIC project; what is they way forward?
  • Bron notes that it came in to JIC through CEN which is not represented today.
  • Nicholas Oughtibridge is the project lead on CONTIS notes its state at the moment as it's gone through ISO but have had to trash some effort due to ballot cycles.
• Keith Boone adds that the process is different but the work groups that see the value in the JIC process should be wiling to commit the effort.

Austin adds that there is a follow on discussion and planning for the next Activities with Other SDOs on Monday Q3 in Frio.